Predicting Local and Distant Recurrence in T1 Colorectal Cancer

Colorectal Cancer Clinical Trial

— T1CR  

Official title:

Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314971
• Other study ID #: 23228/T1CR
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: Ajay Goel, PhD
• Phone: 6262183452
• Email: AJGOEL[@]COH.ORG
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC. This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

Description:

The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM. However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival. This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage I, pT1 colorectal cancer (TNM classification, 8th edition).
• Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines).
• Confirmed cancer-free survivorship at the time of study inclusion.

Exclusion Criteria:

• Lack of informed consent.
• Induction of neoadjuvant systemic therapy before colorectal cancer resection.
• Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.

Related Conditions & MeSH terms

• Colorectal Adenocarcinoma
• Colorectal Cancer
• Colorectal Cancer Recurrent
• Colorectal Cancer Stage I
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Neoplasms
• Recurrence

Intervention

Other:
• Tw1CE
A panel of microRNA and messenger RNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor, with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)

Locations

Country	Name	City	State
Japan	Tokushima University	Tokushima
Spain	Barcelona University	Barcelona
United States	City of Hope Medical Center	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Countries where clinical trial is conducted

United States,  Japan,  Spain, 

References & Publications (28)

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Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 c — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival	Time from curative-intent resection to the development of recurrence (or death)	Up to 60 months